drugset / Trial / NCT02232802

Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.

NCT02232802

Phase 1 Completed 47 enrolled Chemi S.p.A.
RandomizedCrossoverOpen-labelOther

Summary

* The primary objective of the trial is to assess the single-dose relative bioavailability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by subcutaneous (s.c.) injection, under fasting conditions in healthy volunteers. * The secondary objective of the trial is to assess safety and tolerability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection, under fasting conditions in healthy volunteers.

Timeline

Start
2014-08-04
Primary completion
2014-12-05
Completion
2014-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified 80 mg Subcutaneous

Indications

No indication recorded.